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NCT05124834 | Completed | Diabetes Mellitus


System Accuracy of the Blood Glucose Monitor for Personal Use JT100
Sponsor:

Institut fur Diabetes Karlsburg GmbH

Information provided by (Responsible Party):

Matthes Kenning

Brief Summary:

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

Condition or disease

Diabetes Mellitus

Intervention/treatment

blood glucose measurement, blood glucose monitor for personal use

blood glucose measurement, laboratory reference device

Phase

Not Applicable

Detailed Description:

This study assesses the system accuracy the blood glucose monitoring systems for personal use TJ100 pursuant to ISO 15197:2015 guidelines

Study Type : Interventional
Estimated Enrollment : 114 participants
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluierung Der Systemgenauigkeit Des JT100 Blood Glucose Monitoring Systems Der Firma Tyson Bioresearch Inc. gemäß DIN EN ISO 15197:2015
Actual Study Start Date : January 15, 2022
Estimated Primary Completion Date : February 4, 2022
Estimated Study Completion Date : February 4, 2022
Arm Intervention/treatment

Experimental: Subject glucometer measurement

Blood glucose measurement BGM for personal use

Diagnostic Test: blood glucose measurement, blood glucose monitor for personal use

Diagnostic Test: blood glucose measurement, laboratory reference device

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Male or female patients with clinical indication for blood glucose testing
  • Signed form of consent
  • Minimum age of 18 years
  • Subjects are legally competent and capable to understand character, meaning and consequences of the study
Exclusion Criteria
  • Pregnancy or lactation
  • Severe acute disease (at study physician's discretion)
  • Acute or chronic diseases with inherent risk of aggravation by the procedure (at study physician's discretion)
  • Current constitution that does not allow participating in the study (e.g. hematocrit out of
  • the devices's specifications, medication known to influence blood glucose measurements; Appendix A of ISO 15197)
  • Being unable to give informed consent
  • Age younger than 18 years
  • Legally incompetent

System Accuracy of the Blood Glucose Monitor for Personal Use JT100

Location Details


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System Accuracy of the Blood Glucose Monitor for Personal Use JT100

How to Participate

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Locations


Not yet recruiting

Germany, Mecklenburg Vorpommern

Institut für Diabetes Karlsburg GmbH

Karlsburg, Mecklenburg Vorpommern, Germany, 17495

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